Pre-Bent Needle Tips
Ref SN005-1 18GModel SN005-1,SN005-2,SN005-3,SN005-4,SN005-5, SN005-6,SN005-7,SN005-8,SN005-10,SN005-12, SN005-13,SN005-14,SN005-15,SN005-16,SN005-17 SN005-18,SN005-19,SN005-20
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697484312SN005KT 06974843123131 | Date29 Jul 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Endo Irrigation Needle
- Model / Reference
- SN005-1, SN005-2, SN005-3, SN005-4, SN005-5, SN005-6, SN005-7, SN005-8, SN005-10, SN005-12, SN005-13, SN005-14, SN005-15, SN005-16, SN005-17 SN005-18, SN005-19, SN005-20, SN005-1 18G
- Primary DI / UDI-DI
- 06974843123131
- Basic UDI-DI
- 697484312SN005KT
- EMDN Code
- Z12119099 Various dental stomatology instruments - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012353
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from ZOGEAR Medical Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No